Our client, a leading multinational company based in Galway, is seeking to hire three Quality Engineers for an initial 12-month contract, with the potential to turn permanent.
The Role: The Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in moderately complex Quality related projects.
Responsibilities Possesses and applies a broad and increasing knowledge of Quality, and its application to complete moderately complex assignments.
Broad knowledge of operations and practices to enable informed decisions in day to day operations and assignments.
Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly-defined issues.
Identifies problems and possible solutions and takes appropriate action to resolve.Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results.Applies risk assessment techniques in such circumstances.
Drives business improvements through continuous improvement initiatives.
Escalation point for quality related non-conformances and CAPAs.
Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
Requirements Third level qualification.
Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions Competent working knowledge of recognized Quality Management Systems (e.g.
ISO9001/ ISO13485/ ISO14971/ GMP), Awareness of relevant laws and regulations (e.g.
CE/ FDA/ PAL) Broad knowledge of engineering and technical applications applied in development of medical devices useful.
Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits.
Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
For more information and a confidential discussion on the role please contactMichelle Mc Inerney.
Skills: Quality Engineer CAPA